A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer (AndroMETa-CRC-)

AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC).

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries.

Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Telisotuzumab Adizutecan

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane /ID# 268360
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus- Haifa /ID# 267739
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center-Hebrew University /ID# 267579
  • Central District
    • Petah Tikva, Central District, Israel, 4941492
      • Rabin Medical Center. /ID# 267740
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 267741
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 267578
    • Tel Aviv, Tel Aviv, Israel, 6789140
      • Assuta Medical Center - Tel Aviv /ID# 267745
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center /ID# 268237
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 268236
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • The University of Osaka Hospital /ID# 268743
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Saitama Prefectural Cancer Center /ID# 268706
  • Tokyo
    • Chuo-Ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 268713
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials - Rio Piedras /ID# 267888
• South Korea
  • Gyeonggido
    • Seongnam-si, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital /ID# 268592
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 268719
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Yonsei University Health System Severance Hospital /ID# 268718
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center /ID# 268717
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 268720
• Taiwan
  • Changhua City, Changhua County, Taiwan, 50006
    • Changhua Christian Hospital /ID# 270464
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635
  • Kaohsiung City, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital /ID# 267638
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 267631
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital /ID# 270467
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 270468
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital /ID# 267627
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital /ID# 267628
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 267637
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center /ID# 267875
    • Irvine, California, United States, 92618
      • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center /ID# 268131
  • Colorado
    • Golden, Colorado, United States, 80401
      • Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine /ID# 269125
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando /ID# 267970
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University /ID# 266884
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Cancer Institute: Boise /ID# 268095
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610
    • Hinsdale, Illinois, United States, 60521
      • Hope And Healing Cancer Services /ID# 268541
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic - First /ID# 268666
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Cancer Center North /ID# 267965
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic /ID# 267860
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University /ID# 267872
  • Montana
    • Billings, Montana, United States, 59102
      • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey /ID# 268056
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Medical Center /ID# 266879
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center /ID# 267966
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute - Sioux Falls /ID# 268074
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center and Research Institute - Germantown /ID# 268619
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas - Southwestern Medical Center /ID# 268241
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center /ID# 268098
    • Houston, Texas, United States, 77090
      • Millennium Physicians /ID# 268400
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia /ID# 268108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Life expectancy >= 12 weeks per investigator assessment.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Exclusion Criteria:

• Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate [ADC]).
• History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
• Active infection as noted in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telisotuzumab Adizutecan Dose A; Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration.	Drug: Telisotuzumab Adizutecan; Intravenous (IV) Infusion
Experimental: Telisotuzumab Adizutecan Dose B; Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.	Drug: Telisotuzumab Adizutecan; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adverse Events (AE)s	An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.	Up to a Maximum of 4 Years
Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator	Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.	Up to a Maximum of 4 Years
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator	Percentage of participants with clinically significant ECGs findings as assessed by the investigator.	Up to a Maximum of 4 Years
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator	Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.	Up to a Maximum of 4 Years
Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)	OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.	Up to a Maximum of 4 Years
Overall Survival (OS)	OS is defined as the time from randomization to the event of death from any cause.	Up to a Maximum of 4 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by BICR	PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.	Up to a Maximum of 4 Years
OS	OS is defined as the time from randomization to the event of death from any cause	Up to a Maximum of 4 Years
Duration of Response (DOR) as Assessed by BICR	DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by BICR or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.	Up to a Maximum of 4 Years
Disease Control (DC) as Assessed by BICR	DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by BICR.	Up to a Maximum of 4 Years
OR as Assessed by Investigator	OR is defined as confirmed CR or confirmed PR as assessed by investigator per RECIST, version 1.1.	Up to a Maximum of 4 Years
PFS as Assessed by Investigator	PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.	Up to a Maximum of 4 Years
DOR as Assessed by Investigator	DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by BICR or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.	Up to a Maximum of 4 Years
Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan	Maximum observed serum (or plasma, for payload) concentration for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Time to Cmax (Tmax) for Telisotuzumab Adizutecan	Time to Cmax for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan	Terminal elimination half-life for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan	Area under the serum (or plasma, for payload) concentration versus time curve will be determined using noncompartmental methods for total antibody for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan	Antibody drug conjugate for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan	Unconjugated Top1 inhibitor payload for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan	Incidence of anti-drug antibodies for telisotuzumab adizutecan.	Up to a Maximum of 4 Years
Neutralizing Anti-Drug Antibodies (nADAs) for Telisotuzumab Adizutecan	Neutralizing anti-drug antibodies for telisotuzumab adizutecan.	Up to a Maximum of 4 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic Colorectal Cancer; ABBV-400; AndroMETa-CRC-064; Telisotuzumab Adizutecan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; trifluridine tipiracil drug combination
• Other Study ID Numbers: M24-064; 2024-512804-20-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No